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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Blood Circuit, Hemodialysis
510(k) Number K925654
Device Name CD HOME DIALYSERVICE HEMODIALYSIS TRAY
Applicant
Cd Medical, Inc.
14620 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact DIANA UHL
Correspondent
Cd Medical, Inc.
14620 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact DIANA UHL
Regulation Number876.5820
Classification Product Code
KOC  
Date Received11/09/1992
Decision Date 03/30/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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